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| Sponsor: | Taiwan Liposome Company |
|---|---|
| Collaborator: |
Nexus Oncology Ltd |
| Information provided by: | Taiwan Liposome Company |
| ClinicalTrials.gov Identifier: | NCT00747474 |
Purpose
The purpose of this study is to find a safe and tolerable dose of Lipotecan® when administered to patients with advanced solid tumors.
| Condition | Intervention | Phase |
|---|---|---|
|
Advanced Solid Tumors |
Drug: Lipotecan |
Phase I |
| Study Type: | Interventional |
| Study Design: | Treatment, Open Label, Uncontrolled, Single Group Assignment, Safety Study |
| Official Title: | A Phase 1 Open-Label, Sequential Dose Escalation Study Investigating the Safety, Tolerability, and Pharmacokinetics of Intravenous Lipotecan® (TLC388 HCl for Injection) When Administered to Patients With Advanced Solid Tumors |
| Estimated Enrollment: | 40 |
| Study Start Date: | September 2008 |
| Estimated Study Completion Date: | December 2010 |
| Estimated Primary Completion Date: | June 2010 (Final data collection date for primary outcome measure) |
Lipotecan® is a drug product of TLC388 HCl, which is a potent camptothecin analog with cytotoxic activities against a variety of human tumor cell lines in vitro and anti-tumor activities in several xenograft models with human tumor cell lines. Structurally, TLC388 HCl is related to other camptothecins, but it has been chemically modified to improve stability and potency, and to minimize toxicities.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Shu-Chi Hsu, PhD | 650 872 8816 |
| United States, Georgia | |
| Medical College of Georgia | Recruiting |
| Augusta, Georgia, United States, 30912 | |
| Principal Investigator: Sharad Ghamande, MD | |
| United States, Massachusetts | |
| Bidmc, Dfci, Mgh | Recruiting |
| Boston, Massachusetts, United States, 02215 | |
| Principal Investigator: Bruce Dezube, MD | |
| United States, New York | |
| Montefiore Medical Center | Recruiting |
| Bronx, New York, United States, 10461 | |
| Principal Investigator: Sanjay Goel, MD | |
| Taiwan, Taipei | |
| National Taiwan University Hospital | Recruiting |
| Nankang, Taipei, Taiwan | |
| Principal Investigator: Chia-Chi Lin, MD | |
More Information
| Responsible Party: | Taiwan Liposome Company ( Taiwan Liposome Company ) |
| Study ID Numbers: | TLC388-101 |
| Study First Received: | September 3, 2008 |
| Last Updated: | February 2, 2010 |
| ClinicalTrials.gov Identifier: | NCT00747474 History of Changes |
| Health Authority: | United States: Food and Drug Administration |